Euro Roundup: EMA updates Q&A document on publication of clinical trial data

The European Medicines Agency (EMA) has updated its question-and-answer document on the publication of clinical trial data, overhauling the 2018 document.

Officials at EMA created the third version of the Q&A to provide applicants and marketing authorization holders (MAHs) with the information they need to identify, redact, anonymize and submit documents in compliance with the clinical data publication (CDP) policy.

EMA has added 10 new questions to the 2018 document, two of which relate to the scope of the CDP policy. In its responses, EMA clarified that interim study reports and clinical results from ongoing blinded studies are subject to publication.

“In cases where the publication could have an impact on the conduct of the study in a blinded fashion, applicants/MAHs may propose additional redactions to protect from unmasking/unblinding. The implementation of additional redactions to protect from study unmasking/unblinding should be explained in the deviation sections of the Anonymisation Report,” EMA wrote.

In a question on the EMA/Health Canada relationship, EMA explains that “a clinical data package may be jointly reviewed and/or published by EMA and Health Canada.” The agency will consider the approach “for regulatory procedures assessed in parallel by both agencies for which there is a significant overlap in the list of documents in scope for publication.” EMA wants applicants and MAH to request a joint review as soon as possible after receiving an invitation email.

EMA also addresses the invitation process in the updated Q&A. Applicants and MAHs should receive an invitation email from EMA. A new question asks what applicants and MAHs should do if they do not get an email. However, EMA’s response only directs readers to use a web form to ask questions that are not addressed in either the Q&A or another guidance document.

The final new question discusses whether “the requirements for publication of the same Clinical Study Report under Policy 0070 and Clinical Trial Regulation aligned.” In response, EMA outlines similarities between the CDP policy and trial regulation, before acknowledging that further clarification is needed.

“EMA acknowledges that further administrative guidance may be required in relation to the management of the publication of [clinical study reports] falling under the transparency requirements of both Policy 0070 and the Clinical Trial Regulation. EMA is planning to provide additional administrative guidance as part of future updates of this Question and Answer document,” the agency wrote.

EMA Q&A

MHRA shares guidance on labeling and packaging under new Brexit rules

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the labeling and packaging of human medicinal products under the Windsor Framework that will revise the Brexit terms.

Through the Windsor Framework, the UK reversed aspects of the original Brexit agreement with the goal of establishing long-term arrangements for the supply of medicines into Northern Ireland. MHRA will approve and license medicines across the UK, rather than EMA covering Northern Ireland. The framework also ends the application of the Falsified Medicines Directive (FMD) in Northern Ireland.

The changes will take effect at the start of 2025. Ahead of that date, MHRA has detailed what companies that supply medicines for human use need to do to adapt to the framework.

From 1 January 2025, all UK medicinal products must carry a “clearly legible” label that states “UK Only” to prevent their sales in Ireland and other parts of the European Union. The label must be presented on the outer packaging and use “at least 7-point font.”

“To provide a single deadline for new packaging requirements, the MHRA will continue to allow manufacturers to supply medicines in legacy EU packaging until 31 December 2024. This extends the previous 31 December 2023 deadline, which required medicines for GB to be presented in GB compliant packaging, by one year,” the agency wrote.

Manufacturers can apply the “UK Only” statement using a sticker until 30 June 2025. After that date, “UK Only” must be printed directly onto the packaging. The guidance also covers the disapplication of FMD from Northern Ireland and other implications of the framework.

MHRA Guidance

Swiss-US mutual recognition agreement on manufacturing practices takes effect

The good manufacturing practice (GMP) mutual recognition agreement (MRA) between Switzerland and the United States has come into effect.

Government officials signed off on the MRA in December 2022 and January 2023. Since then, the US Food and Drug Administration (FDA) and the Swiss Agency for Therapeutic Products (Swissmedic) have “scrutinized each other’s processes for monitoring medicinal product manufacturers in their respective countries and found them to be comparable,” according to the Swiss regulatory agency.

The scrutiny has positioned Swissmedic and FDA to accept the results of each other’s GMP inspections. Swissmedic outlined what that will mean in practice in a notice about the activation of the MRA.

“Before an inspection is conducted by the FDA in Switzerland or by Swissmedic in the USA, it will be necessary to check whether the production site in question has already been inspected,” Swissmedic said. “If so, GMP documents will be made available to the partner authority, subject to consent being given by the manufacturer. These documents can then be used to evaluate the manufacturer instead of conducting an on-site inspection.”

Swissmedic Notice

Medical devices excluded from UK’s backdown on recognition of CE marks

MHRA has clarified that the UK government’s decision to support “indefinite CE mark recognition” does not apply to medical devices.

As part of the Brexit process, the UK created the UKCA, its equivalent of the CE mark used to certify a wide range of products including medical devices. The UK planned to stop recognizing CE marks and start using UKCA in 2024. However, officials announced indefinite recognition of the CE mark this week “to prevent a cliff-edge moment” and spare businesses from uncertainty and “unnecessary costs.”

The revised policy applies to 18 regulations that fall under the Department for Business and Trade, including personal protective equipment. However, the broader medical device sector is outside of the scope of the CE mark policy, as MHRA explained.

“The extended recognition of CE marking announced this morning does not apply to medical devices or IVDs,” MHRA said. “The government has already put in place legislation that amends The Medical Device Regulations 2002 to extend the acceptance of CE marked medical devices on the Great Britain market.”

As such, the previously disclosed transition from the CE mark to UKCA still applies to medical devices. The UK is set to stop accepting CE-marked medical devices between 2028 and 2030, depending on the regulatory regimes covering the technologies.

Press Release, MHRA Notice

Other news:

EMA has posted its opinion on a potential primary endpoint for Duchenne muscular dystrophy clinical trials. The agency concluded that the Stride velocity 95th centile qualifies as a primary endpoint in superiority studies as an alternative to the 6-minute walking test. EMA reached the conclusion after reviewing feedback from companies including Pfizer and Roche. EMA Opinion, Industry Feedback

Euro Roundup: EMA updates Q&A document on publication of clinical trial data

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